U.S. patent application number 14/530894 was filed with the patent office on 2015-02-19 for devices, systems, and methods for deforming a body channel.
The applicant listed for this patent is CVDevices, LLC. Invention is credited to Ghassan S. Kassab, Jose A. Navia, SR..
Application Number | 20150051443 14/530894 |
Document ID | / |
Family ID | 52467285 |
Filed Date | 2015-02-19 |
United States Patent
Application |
20150051443 |
Kind Code |
A1 |
Kassab; Ghassan S. ; et
al. |
February 19, 2015 |
DEVICES, SYSTEMS, AND METHODS FOR DEFORMING A BODY CHANNEL
Abstract
Devices, system and methods for deforming body channels are
disclosed herein. At least some embodiments described may be used
to deform a body channel so as to decrease or prevent the normal
intrachannel flow of material within the body channel. Such
deformation may be used to treat such maladies as Gastroesophageal
Reflux Disease.
Inventors: |
Kassab; Ghassan S.; (La
Jolla, CA) ; Navia, SR.; Jose A.; (Buenos Aires,
AR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CVDevices, LLC |
San Diego |
CA |
US |
|
|
Family ID: |
52467285 |
Appl. No.: |
14/530894 |
Filed: |
November 3, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12602346 |
Nov 30, 2009 |
8876690 |
|
|
14530894 |
|
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Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61F 5/005 20130101;
A61F 2/0018 20130101; A61F 2250/0001 20130101; A61F 2250/0002
20130101; A61F 2210/009 20130101; A61B 2017/00827 20130101; A61B
2017/00805 20130101; A61F 2/04 20130101; A61F 5/0053 20130101; A61F
2002/044 20130101; A61F 2/0031 20130101; A61F 2/0036 20130101; A61F
5/0066 20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. A device, comprising: a first portion extending from a first end
to an opposite second end, the first portion sufficiently rigid so
as to exert a force upon a body channel to deform the body channel
when positioned thereon; a first element at the first end and a
second element at the second end, the first element and the second
element magnetically attracted to one another; and a second portion
substantially surrounding the first portion, the second portion
being sufficiently malleable to distribute the force exerted upon
the body channel by the first portion.
2. The device of claim 1, wherein the first element comprises a
first magnet.
3. The device of claim 1, wherein the first element comprises a
first electromagnet, and wherein the first element is magnetically
attracted to the second element when the first electromagnetic is
activated.
4. The device of claim 1, wherein the first element is proximate to
the first end, and wherein the second element is proximate to the
second end.
5. The device of claim 1, comprising part of a system, the system
further comprising: a first wire positioned adjacent to at least
one of the first element and the second element, the first wire
configured to transmit an electric current from a power source to
the at least one of the first element and the second element.
6. The device of claim 5, wherein the system further comprises the
power source.
7. The device of claim 5, wherein the at least one of the first
element and the second element generates a magnetic field when the
first wire transmits the electric current thereto.
8. The device of claim 1, wherein the first end and second end
exhibit a transient magnetic force, and wherein the device is
capable of deforming the body channel through the transient
magnetic force.
9. The device of claim 3, wherein the second element comprises a
second electromagnet.
10. The device of claim 6, wherein the system further comprises: a
control mechanism configured to operate the power source.
11. The device of claim 10, wherein the system further comprises: a
sensor in communication with the control mechanism, the sensor
configured to obtain data relating to at least one of a flow rate,
a pressure, and/or a temperature for use by the control mechanism
to operate the power source.
12. The device of claim 1, further comprising: a joint member
partitioning along the first portion between the first end and the
second end, the joint member configured so allow flexure of the
first portion.
13. The device of claim 1, further comprising: a third element
positioned between the first end and the second end, the third
element configured to increase potential deformative force of the
device.
14. The device of claim 1, wherein the body channel comprises a
portion of a mammalian gastrointestinal system, and wherein the
device is configured to control the flow of a substance within the
mammalian gastrointestinal system.
15. A system, comprising: a first device, comprising: a first
portion extending from a first end to an opposite second end, the
first portion sufficiently rigid so as to exert a force upon a body
channel to deform the body channel when positioned thereon; a first
element at the first end and a second element at the second end; a
second portion substantially surrounding the first portion, the
second portion being sufficiently malleable to distribute the force
exerted upon the body channel by the first portion; and a second
device, comprising: a third portion extending from a third end to
an opposite fourth end, the third portion sufficiently rigid so as
to exert a force upon the body channel to deform the body channel
when positioned thereon; a third element at the third end and a
fourth element at the fourth end; and a fourth portion
substantially surrounding the third portion, the fourth portion
being sufficiently malleable to distribute the force exerted upon
the body channel by the third portion; wherein the first element
and the fourth element magnetically attracted to one another; and
wherein the second element and the third element magnetically
attracted to one another.
16. The system of claim 15, wherein at least one of the first
element, the second element, the third element, and the first
element comprises an electromagnet capable of generating a magnetic
field when an electric current is provided thereto.
17. The system of claim 15, further comprising: a control mechanism
configured to operate a power source operably coupled to at least
one of the first device and the second device; and a sensor in
communication with the control mechanism, the sensor configured to
obtain data for use by the control mechanism to operate the power
source.
18. A system, comprising: a first device and a second device, each
comprising: a first portion extending from a first end to an
opposite second end, the first portion sufficiently rigid so as to
exert a force upon a body channel to deform the body channel when
positioned thereon; a first element at the first end and a second
element at the second end, the first element of the first device
attracted to the first element of the second device and the second
element of the first device attracted to the second element of the
second device; a second portion substantially surrounding the first
portion, the second portion being sufficiently malleable to
distribute the force exerted upon the body channel by the first
portion; and a first wire positioned adjacent to the first portion
of the first device, the first wire configured to transmit an
electric current from a power source to the first portion of the
first device so to cause the first device to exhibit a transient
magnetic force.
19. The system of claim 18, further comprising: a second wire
positioned adjacent to at least one of the first portion and the
second portion of the second device, the second wire configured to
transmit an electric current from the power source to the at least
one of the first portion and the second portion of the second
device to cause the second device to exhibit a second transient
magnetic force.
20. The system of claim 18, further comprising: a control module
operably coupled to the first device, the control module configured
to control operation of the first device by way of controlling
administration of electric current from a power source to the first
device.
Description
PRIORITY
[0001] The present application is related to, claims the priority
benefit of, and is a U.S. continuation application of, U.S. patent
application Ser. No. 12/602,346, filed Nov. 30, 2009, which is
related to, claims the priority benefit of, and is a U.S. national
stage application of, International Patent Application Serial No.
PCT/US2008/065099, filed May 29, 2008, which is related to, and
claims the priority benefit of, U.S. Provisional Patent Application
No. 60/940,604, filed May 29, 2007, the contents of which are
incorporated by reference in their entirety into this
disclosure.
BACKGROUND
Acid Reflux
[0002] Gastroesophageal Reflux Disease (GERD) is defined as
symptoms of mucosal damage produced by the abnormal reflux of
gastric contents into the esophagus. GERD is a condition in which
the acidified liquid content of the stomach backs up into the
esophagus. The causes of GERD comprise an abnormal lower esophageal
sphincter, hiatal hernia, abnormal esophageal contractions, and
slow emptying of the stomach.
[0003] Approximately 4.6 to 18.6 million people in the United
States have GERD. GERD can have a significant impact on quality of
life. GERD can be classified in two ways: uncomplicated GERD or
complicated GERD. The symptoms of uncomplicated GERD are heartburn,
regurgitation, and nausea. Complications of GERD include ulcers and
strictures of the esophagus, Barrett's esophagus, cough and asthma,
throat and laryngeal inflammation, inflammation and infection of
the lungs, and collection of fluid in the sinuses and middle ear.
Barrett's esophagus is a pre-cancerous condition that requires
periodic endoscopic surveillance for the development of cancer.
GERD is treated with life-style changes, antacids, histamine
antagonists (H2 blockers), proton pump inhibitors (PPIs),
pro-motility drugs, foam barriers, surgery, and endoscopy.
Urinary Incontinence
[0004] Urinary incontinence is the inability to control the release
of urine from the bladder. The loss of bladder control--known as
urinary incontinence--is an all too common, often embarrassing and
frustrating problem for millions of people. The five main types of
urinary incontinence are stress incontinence, urge incontinence,
overflow incontinence, mixed incontinence and functional
incontinence. Other types of urinary incontinence include reflex
incontinence, total incontinence and nocturnal enuresis.
[0005] More often, urinary incontinence is a persistent condition
caused by some underlying physical problem such as weakened
muscles, nerve problems or an obstruction in the urinary tract.
Factors that can lead to chronic incontinence include pregnancy and
childbirth, hormonal changes following menopause, hysterectomy,
interstitial cystitis, prostatitis, enlarged prostate, prostate
cancer, bladder cancer, neurological disorders, obstruction and
other illnesses or injuries.
[0006] Urinary incontinence can often be corrected with the help of
medication but there are frequently side effects. Several medical
devices are available to help treat incontinence. Those designed
specifically for women include urethral inserts and pessaries.
Urethral inserts are small tampon-like disposable devices.
Pessaries are small plastic or silicone ring-like devices that are
inserted into the vagina to support the bladder.
[0007] A common surgical procedure is replacement of the urinary
sphincter with an artificial one. The artificial sphincter is a
small device and is particularly useful to men who have weakened
urinary sphincters from treatment of prostate cancer or an enlarged
prostate gland. The procedure is rarely performed on women with
stress incontinence. The device is shaped like a doughnut and is
implanted around the neck of the bladder. The fluid-filled ring
keeps the urinary sphincter shut tight until the patient is ready
to urinate. To urinate, the patient presses a valve implanted under
the skin that causes the ring to deflate and allows urine in the
bladder to be released. This surgery is the most effective
procedure for male incontinence. Complications of this procedure is
malfunction of the device, which implies a repeat surgery, and
infrequent infection.
Fecal Incontinence
[0008] Fecal incontinence refers to the involuntary loss of gas or
liquid stool (called minor incontinence) or the involuntary loss of
solid stool (called major incontinence). Surveys indicate the
incidence in the general population to be 2-7 percent, although the
true incidence may be much higher because many people are hesitant
to discuss this problem with a healthcare provider.
[0009] Fecal incontinence can undermine self-confidence, create
anxiety, and lead to social isolation. Fecal incontinence is most
often caused by injury to one or both of the ring-like muscles, or
the nerves that control these muscles, at the end of the rectum
called the internal and external anal sphincters. Causes of fecal
incontinence can include vaginal childbirth, neurologic disorders,
and fecal impaction. In some cases, the cause is unknown. Treatment
options for fecal incontinence may include a combination of
medication, behavioral changes, stool bulking agents, and
surgery.
BRIEF SUMMARY
[0010] Various embodiments relate to devices, systems, and methods
for deforming a body structure. At least some embodiments may be
used to treat a condition associated with a malfunctioning or
poorly functioning body structure. An example of one embodiment
used to treat a condition is for the treatment of GERD with a
poorly functioning lower esophageal sphincter.
[0011] According to at least one embodiment of a device for the
deformation of a body channel, the device comprises a first rod
having a first end, a second end, a first portion extending from
the first end to the second end, and a second portion substantially
surrounding the first portion, wherein the first end and second end
are operable to attract one another, wherein the first portion of
the first rod is sufficiently rigid as to exert a force upon a body
channel, and wherein the second portion of the first rod comprises
a malleable portion sufficient to distribute the force of the first
portion exerted upon the body channel. In at least one additional
embodiment, the first end and second end display a transient
magnetic force, and the first rod is capable of deforming a body
channel through the transient magnetic force. In an additional
embodiment, the first rod further comprises a first ferromagnetic
bar proximate to a first end and a second ferromagnetic bar
proximate to the second end, and a first wire having a proximal
wire end and a distal wire end, wherein at least a portion of the
first wire is in contact with a portion of the first rod, and
wherein the first wire is capable of generating a magnetic field.
In yet another embodiment, the magnetic field generates a transient
magnetic force between the first ferromagnetic bar and the second
ferromagnetic bar.
[0012] In at least one embodiment of a device for deformation of a
body channel, the device further comprises a power source, the
power source electrically coupled to the first wire. In at least
one embodiment, the power source is operable to provide an electric
current to the first wire. In an additional embodiment, the power
source comprises a battery. In yet another embodiment, the power
source further comprises a control mechanism and a processor
operable to process data.
[0013] In at least one embodiment of the deformation device, the
control mechanism of the deformation device is capable of manual
and/or automatic adjustment. In at least one embodiment, the device
further comprises a sensor in communication with the power source.
The sensor, in at least one embodiment, is operable to detect a
predetermined variable. In yet another embodiment, the sensor is
operable to detect any one of the deformation of the body channel,
the flow of a material within the body channel, a level of pressure
exerted by the first rod on the body channel, and temperature. In
an additional embodiment, the control mechanism is adjusted
automatically through use of the processor by the sensor upon
reaching a preset value for the predetermined variable.
[0014] In at least one embodiment of the deformation device, the
first rod further comprises a joint member, wherein the joint
member partitions the first rod into a proximal segment and a
distal segment. In at least one embodiment, the joint member allows
flexure of the first rod.
[0015] In yet another embodiment of the deformation device, the
deformation device further comprises a sleeve at least partially
sheathing a portion of the first rod. In at least one embodiment,
the sleeve may be comprised of any one of silicone,
polytetrafluoroethylene, a biological material, small intestinal
submucosal material, pericardial tissue. The sleeve, in at least
one embodiment, substantially shields exterior surfaces from
contact with the electric current.
[0016] In at least one embodiment, the deformation device is
proximate to the body channel. Further, in an additional
embodiment, the device is secured proximate to the body channel by
a securing mechanism.
[0017] In addition to the two ferromagnetic bars of the embodiment
of the deformation device, in at least one embodiment, the first
rod further comprises at least one additional ferromagnetic bar
located between the first ferromagnetic bar and the second
ferromagnetic bar. In an additional embodiment, at least one of the
additional ferromagnetic bars is configured to increase a potential
deformative force of the first rod. In yet another embodiment, at
least one of the ferromagnetic bars comprises neodymium, iron, and
boron. Additionally, in at least one embodiment, at least one of
the ferromagnetic bars comprises a Heusler alloy or of
carbon-coated metal particles. In yet another embodiment, at least
one of the ferromagnetic bars consists of a material selected from
the group consisting of Cu.sub.2MnAl, Cu.sub.2MnIn, Cu.sub.2MnSn,
Ni.sub.2MnAl, Ni.sub.2MnIn, Ni.sub.2MnSn, Ni.sub.2MnSb,
Co.sub.2MnAl, Co.sub.2MnSi, Co.sub.2MnGa, Co.sub.2MnGe,
Pd.sub.2MnAl, Pd.sub.2MnIn, Pd.sub.2MnSn, and Pd.sub.2MnSb.
Further, in at least one embodiment, the first end of the first rod
is in proximity to the second end of the first rod, and the first
ferromagnetic bar is capable of magnetic attraction to the second
ferromagnetic bar.
[0018] According to at least one embodiment of a device for the
deformation of a body channel, the device comprises a first rod
having a first end, a second end, a first portion and a second
portion, a second rod having a third end, a fourth end, a third
portion and a fourth portion, wherein the first end and the fourth
end are operable to attract one another, and the second end and the
third end are operable to attract one another, wherein at least two
of the first end, the second end, the third end and the fourth end
display a transient magnetic force, and the first rod and second
rod in conjunction are capable of deforming a body channel through
a transient magnetic attractive force. In an additional embodiment,
at least one of the first portion and the third portion are
sufficiently rigid as to exert a force upon a body channel, and
wherein at least one of the second portion and the fourth portion
comprise a malleable portion sufficient to distribute the force of
the first portion exerted upon the body channel.
[0019] According to at least one embodiment of a system for the
deformation of a body channel, the system comprises a first rod
having a first end, a second end, a first ferromagnetic bar
proximate to the first end and a second ferromagnetic bar proximate
to the second end, a first wire having a proximal wire end and a
distal wire end, wherein at least a portion of the first wire is in
contact with a portion of the first rod, a power source operably
connected to the first wire, the power source operable to provide
an electric current to the first wire, and wherein deliverance of
an electric current from the power source to the first wire forms
an inductor. In an additional embodiment, the inductor generates a
transient magnetic attractive force between the first ferromagnetic
bar and the second ferromagnetic bar. In at least one embodiment,
the power source comprises a battery. In at least one further
embodiment, the power source further comprises a control mechanism
and a processor for processing data.
[0020] In at least one embodiment of the system for deforming a
body channel, the control mechanism of the system is capable of
manual and/or automatic adjustment. In at least one embodiment, the
system further comprises a sensor in communication with the power
source. The sensor, in at least one embodiment, is operable to
detect a predetermined variable. In yet another embodiment, the
sensor is operable to detect any one of the deformation of the body
channel, the flow of a material within the body channel, a level of
pressure exerted by the first rod on the body channel, and
temperature. In an additional embodiment, the control mechanism is
adjusted automatically through use of the processor by the sensor
upon reaching a preset value for the predetermined variable.
[0021] In at least one embodiment of the system, the first rod
further comprises a joint member, wherein the joint member
partitions the first rod into a proximal segment and a distal
segment. In at least one embodiment, the joint member allows
flexure of the first rod.
[0022] In yet another embodiment of the system, the system further
comprises a sleeve at least partially sheathing a portion of the
first rod. In at least one embodiment, the sleeve may be comprised
of any one of silicone, polytetrafluoroethylene, a biological
material, small intestinal submucosal material, and pericardial
tissue. The sleeve, in at least one embodiment, substantially
shields exterior surfaces from contact with the electric
current.
[0023] In at least one embodiment, the system for deforming a body
channel is proximate to the body channel. Further, in an additional
embodiment, the system is secured proximate to the body channel by
a securing mechanism.
[0024] In addition to the two ferromagnetic bars of the system, in
at least one embodiment, the first rod further comprises at least
one additional ferromagnetic bar located between the first
ferromagnetic bar and the second ferromagnetic bar. In an
additional embodiment, at least one of the additional ferromagnetic
bars is configured to increase the potential deformative force of
the first rod. In yet another embodiment, at least one of the
ferromagnetic bars comprises neodymium, iron, and boron.
Additionally, in at least one embodiment, at least one of the
ferromagnetic bars comprises a Heusler alloy or carbon-coated metal
particles. In yet another embodiment, at least one of the
ferromagnetic bars consists of a material selected from the group
consisting of Cu.sub.2MnAl, Cu.sub.2MnIn, Cu.sub.2MnSn,
Ni.sub.2MnAl, Ni.sub.2MnIn, Ni.sub.2MnSn, Ni.sub.2MnSb,
Co.sub.2MnAl, Co.sub.2MnSi, Co.sub.2MnGa, Co.sub.2MnGe,
Pd.sub.2MnAl, Pd.sub.2MnIn, Pd.sub.2MnSn, and Pd.sub.2MnSb.
Further, in at least one embodiment, the first end of the first rod
is in proximity to the second end of the first rod, and the first
ferromagnetic bar is capable of magnetic attraction to the second
ferromagnetic bar.
[0025] According to at least one embodiment of a system for
deformation of a body channel, the system further comprises a
second rod having a third end, a fourth end, a third ferromagnetic
bar proximate to the third end and a fourth ferromagnetic bar
proximate to the fourth end, a second wire having a proximal second
wire end and a distal second wire end, a portion of the second wire
coiled around a portion of the second rod, and a power source
operably connected to the second wire, the power source operable to
provide an electric current to the second wire, wherein deliverance
of an electric current from the power source to the second wire
forms an inductor, and wherein the first rod and the second rod are
operable for attraction.
[0026] According to at least one embodiment of a method for the
deformation of a body channel, the method comprises introducing
proximate to a body channel a deformation device operable to deform
a body channel, wherein the deformation device is operably coupled
to a first wire, and wherein the first wire is operably connected
to a power source, positioning the deformation device to
substantially encircle the body channel, securing the deformation
device at a point proximate to the body channel and introducing an
electrical current from the power source to the first wire to form
an inductor. In an additional embodiment of the method, the device
comprises a first rod having a first end, a second end, a first
ferromagnetic bar proximate to the first end and a second
ferromagnetic bar proximate to the second end. In yet another
embodiment of the method, the method further comprises constricting
the body channel. Further, in an additional embodiment of the
method, the body channel is selected from a group consisting of
the: upper esophageal sphincter, lower esophageal (or cardia)
sphincter, pyloric sphincter, Illeocecal sphincter, sphincter of
Oddi, urethral sphincter, internal anal sphincter, and external
anal sphincter. In at least one additional embodiment, the method
further comprises introducing a biologically compatible material
sheathing the first rod. In an additional embodiment of the method,
at least one of the ferromagnetic bars comprises neodymium, iron,
and boron. In an additional embodiment, at least one of the
ferromagnetic bars comprises a Heusler alloy or carbon-coated metal
particles. Further, in at least one additional embodiment, at least
one of the ferromagnetic bars consist of a material selected from
the group consisting of Cu.sub.2MnAl, Cu.sub.2MnIn, Cu.sub.2MnSn,
Ni.sub.2MnAl, Ni.sub.2MnIn, Ni.sub.2MnSn, Ni.sub.2MnSb,
Co.sub.2MnAl, Co.sub.2MnSi, Co.sub.2MnGa, Co.sub.2MnGe,
Pd.sub.2MnAl, Pd.sub.2MnIn, Pd.sub.2MnSn, and Pd.sub.2MnSb.
[0027] In an additional embodiment of the method for deforming a
body channel, the method further comprises removing the electrical
current from the first wire. Additionally, the method, in at least
one embodiment, further comprises introducing a control mechanism.
In at least one embodiment, the control mechanism comprises a
sensor operably connected to the power source. Further, in at least
one embodiment, the control mechanism monitors at least one of:
flow, pressure, strain, and deformation of the body channel.
Additionally, in at least one embodiment, the control mechanism
automatically controls the supply of electrical current to the
first rod. The power source, in at least one embodiment of the
method, comprises a battery. Additionally, in at least one
embodiment, the power source is implanted subcutaneously.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 shows the magnetic field of two ferromagnetic rods
arranged above and below a valve annulus, according to a previous
disclosure;
[0029] FIG. 2 shows two ferromagnetic rods in the form of magnetic
dipoles with electric current being applied, according to a
previous disclosure;
[0030] FIG. 3 shows a depiction of the computation of horizontal
force exerted between two magnets, according to a previous
disclosure;
[0031] FIG. 4 shows a top view of at least one embodiment of a
deformation device of the present disclosure, as described
herein;
[0032] FIG. 5A shows at least one embodiment of a deformation
device of FIG. 4 positioned around a body channel, as described
herein;
[0033] FIG. 5B shows at least one embodiment of a deformation
device of FIG. 4 positioned around to a body channel and exerting
moderate deformation pressure to the body channel, as described
herein;
[0034] FIG. 5C shows at least one embodiment of a deformation
device of FIG. 4 positioned around to a body channel and exerting
severe deformation pressure to the body channel, as described
herein;
[0035] FIG. 6 shows a top view of at least one embodiment of a
deformation device, as described herein;
[0036] FIG. 7 shows a top view of at least one embodiment of a
deformation device, as described herein;
[0037] FIG. 8 shows a top view of at least one embodiment of a
deformation device, as described herein;
[0038] FIG. 9 shows a top view of at least one embodiment of a
deformation device, as described herein; and
[0039] FIG. 10 shows a diagram of an embodiment of the power
source, as described herein.
DETAILED DESCRIPTION
[0040] The present disclosure relates to deformation devices and
methods of their use in the deformation of body channels. For the
purposes of promoting an understanding of the principles of the
present disclosure, reference will now be made to the embodiments
illustrated in the drawings, and specific language will be used to
describe the same. It will nevertheless be understood that no
limitation of the scope of the present disclosure is thereby
intended.
[0041] The disclosed embodiments include devices, systems and
methods for the deformation of a body channel. For example, at
least some of the embodiments disclosed herein are useful for the
deformation of the esophagus, including in some embodiments the
lower esophageal sphincter. Such deformation can be used in the
treatment of GERD, as referenced herein. Additionally, at least
some embodiments disclosed herein are useful for the deformation of
the urethra, including in some instances the urinary sphincter, for
treatment of urinary incontinence. Further, at least some
embodiments disclosed herein are useful for the deformation of the
rectum, including in some instances the internal and/or external
anal sphincter, for treatment of fecal incontinence.
[0042] Previously, the present inventors introduced an invention
(U.S. Patent Application No. 60/881,836, later converted to
International Application No. PCT/US08/00840) aimed at adjusting or
remodeling a valve annulus through electromagnetic force. FIGS. 1-3
show some of the concepts introduced in the prior application, and
used in the determination of the motion of the annulus. FIG. 1
shows the magnetic fields generated by two ferromagnetic rods
arranged above and below a valve annulus (not shown). In this
embodiment, the black squares represent ferromagnetic elements, and
the arrows represent the lines of magnetic force.
[0043] FIG. 2 shows two ferromagnetic rods in the form of magnetic
dipoles, with current applied through lead wires in a coiled
arrangement around the ferromagnetic rods to form an inducer. FIG.
3 shows a depiction of how to compute the horizontal force
generated between magnets as disclosed in the prior application
referenced herein.
[0044] FIG. 4 shows a top-down view of at least one embodiment of
deformation device for the deformation of a body channel. In the
embodiment depicted in FIG. 4, deformation device 400 comprises a
first rod 402 having a first end 404 and a second end 406. First
rod 402 further comprises a first portion 408 and a second portion
410, wherein first portion 408 is comprised of a material
sufficiently rigid as to exert a force upon a body channel, and
wherein second portion 410 is comprised of a material sufficiently
malleable as to distribute the force of the first portion 408 upon
an affected body channel.
[0045] First portion 408, may be comprised of any sufficiently
rigid material, such as a metal, plastic, composite, or biological
material. In at least one embodiment, second portion 410 may be
comprised of any one of a silicone material, biological material
(SIS, pericardium, etc.), PTFE or other biologically compatible and
protective material. In at least one embodiment, second portion 410
may also be comprised of an electrically-protective material.
[0046] First end 404 and second end 406 of first rod 402 comprise
magnets 412 and 414 respectively, with opposing polarities so that
opposing poles of the magnets attract one another. The force of
attraction between magnets 412 and 414, in at least this
embodiment, may be sufficient to urge first end 404 and second end
406 so as to decrease the distance between the two ends. In at
least one embodiment, the magnetic attractive force between magnets
412 and 414 may be of a transient nature. Further, magnets 412 and
414 may be of any size or shape as may be useful exert deformation
pressure on a body channel. In at least one embodiment, magnets 412
and 414 may be comprised of any ferromagnetic material known in the
art.
[0047] FIG. 5A shows an embodiment of deformation device 400 of
FIG. 4 where the deformation device 400 is at least partially
surrounding exterior wall 504 of a body channel 502. The body
channel 502 further comprises an interchannel space 506. In at
least one embodiment, the interchannel space 506 may contain, or
allow the passage of, a biological liquid or solid.
[0048] As shown in FIGS. 5B and 5C, as the deformation device 400
begins to exert force upon exterior wall 504, the volume of
interchannel space 506 beings to decrease. This decrease in volume
may lower the efficiency of passage of a liquid or solid to the
point where it is substantially stopped. Compression of the space
between the first end 404 and second end 406 of deformation device
400 under moderate magnetic force, as shown in FIG. 5B, passes a
significant amount of compressile force onto exterior wall 504 to
effect the compression of interchannel space 506. Introduction of
severe force upon body channel 502, as depicted in FIG. 5C,
produces a significant reduction in volume of interchannel space
506.
[0049] Deformation device 400 is sized and shaped in such a manner
as to sufficiently encompass the exterior wall 504. In at least one
embodiment, the composition of first rod 402 may be of a shape
memory alloy or similar material to allow for the shaping of first
rod 402 to the surface of the body channel 502.
[0050] FIG. 6 shows an additional embodiment of a deformation
device of the present disclosure. As shown in FIG. 6, an embodiment
of deformation device 600 comprising a first rod 602 having a first
end 604 and a second end 606 is provided. First rod 602 further
comprises a first portion 608 and a second portion 610, wherein
first portion 608 is comprised of a material sufficiently rigid as
to exert a force upon a body channel, and wherein second portion
610 comprised of a material sufficiently malleable as to distribute
the force of first portion 608 upon an affected body channel. First
rod 602 further comprises ferromagnetic bars 612 and 614 proximate
to first end 604 and second end 606 of first rod 602. Ferromagnetic
bars 612 and 614 are in contact with wire 622 electrically coupled
to a power supply 620. Upon introduction of an electrical current
to wire 622, ferromagnetic bars 612 and 614 display a transient
magnetic force towards one another. The device, in some
embodiments, may be configured such that when the electric current
is turned off the transient magnetic force decreases and/or ceases.
Further, in at least one embodiment, the level of magnetic
attraction may be adjusted through modification of the level of
current applied to wire 622. In at least one embodiment, first rod
602 may further comprise at least one additional ferromagnetic bar
between ferromagnetic bars 612 and 614. By way of example, at least
one embodiment depicted in FIG. 6 discloses two ferromagnetic bars
616 and 618 between ferromagnetic bars 612 and 614. This depiction
is in no way meant to be a limitation on the number or spacing of
ferromagnetic bars which may be placed depending on the intended
location and usage of deformation device 600.
[0051] FIG. 7 shows an additional embodiment of a deformation
device of the present disclosure. As shown in FIG. 7, an embodiment
of deformation device 700 which comprises similar components to
deformation device 600 save for the inclusion of joint member 722
is provided. Deformation device 700 comprises first rod 702 having
first end 704 and second end 706. First rod 702 further comprises a
first portion 708 and a second portion 710, wherein first portion
708 is comprised of a material sufficiently rigid as to exert a
force upon a body channel, and wherein second portion 710 is
comprised of a material sufficiently malleable as to distribute the
force of first portion 708 upon an affected body channel. First rod
702 further comprises ferromagnetic bars 712 and 714 proximate to
first end 704 and second end 706, respectively. Ferromagnetic bars
712 and 714 are in contact with wire 724 electrically coupled to a
power supply 720. Upon introduction of an electrical current into
wire 724, ferromagnetic bars 712 and 714 display a transient
magnetic force towards one another. In at least this embodiment,
first rod 702 may comprise two additional ferromagnetic bars 716
and 718 between ferromagnetic bars 712 and 714.
[0052] Joint member 722 serves to decrease the resistance to
flexure of first rod 702 and substantially serves to divide first
rod 702 into a proximal and distal region. Inclusion of joint
member 722 into deformation device 700 may be dependent upon the
site of application and the usage envisioned by the practitioner.
For example, the inclusion of joint member 722 may be indicated in
an embodiment of first rod 702 comprising a material lacking
sufficient flexure to flex in response to the magnetic force
generated by the ferromagnetic bars.
[0053] FIG. 8 shows an additional embodiment of a deformation
device of the present disclosure. As shown in FIG. 8, an embodiment
of deformation device 800 comprising similar components to
deformation device 700 save for the inclusion of sleeve 824.
Deformation device 800 comprises first rod 802 having first end 804
and second end 806. First rod 802 further comprises first portion
808 and second portion 810, wherein first portion 808 is comprised
of a material sufficiently rigid as to exert a force upon a body
channel, and wherein second portion 810 is comprised of a material
sufficiently malleable as to distribute the force of first portion
808 upon an affected body channel. First rod 802 further comprises
ferromagnetic bars 812 and 814 proximate to first end 804 and
second end 806, respectively. Ferromagnetic bars 812 and 814 are in
contact with wire 824 electrically coupled to power supply 820.
Upon introduction of an electrical current into wire 824,
ferromagnetic bars 812 and 814 display a transient magnetic force
towards one another. In at least this embodiment, first rod 802 may
comprise two additional ferromagnetic bars 816 and 818 between
ferromagnetic bars 812 and 814.
[0054] Joint member 822 serves to decrease the resistance to
flexure of first rod 802 and substantially serves to divide first
rod 802 into a proximal and distal region. Inclusion of joint
member 822 into deformation device 800 may be dependent upon the
site of application and the usage envisioned by the practitioner.
For example, the inclusion of joint member 822 may be indicated in
an embodiment of first rod 802 comprising a material lacking
sufficient flexure to flex in response to the magnetic force
generated by the ferromagnetic bars.
[0055] In at least one embodiment, sleeve 824 is comprised of a
biologically compatible material with edges defining an opening at
either end. The openings are sufficiently sized and shaped as to
removably engage either end 804 or 806 of first rod 802. In at
least one embodiment, as depicted in FIG. 8, sleeve 824 is coupled
to at least one end of first rod 802. Sleeve 824 at least partially
sheaths a portion of first rod 802 from interaction with exterior
surfaces.
[0056] In at least one embodiment, the biologically compatible
material of sleeve 824 may be either silicon or
polytetrafluroethylene. Additionally, in some embodiments sleeve
824 may be comprised of a biological material such as pericardium
or submucosal material from the small intestine marketed under the
name SIS (Cook Biotech). Further, in at least one embodiment, the
biologically compatible material of sleeve 824 is minimally
conductive to electric currents.
[0057] FIG. 9 shows an exemplary embodiment of deformation device
900, where device 900 comprises first rod 902 and second rod 916.
First rod 902 comprises first end 904 and second end 906. First rod
902 further comprises first portion 908 and second portion 910,
wherein first portion 908 is comprised of a material sufficiently
rigid as to exert a force upon a body channel, and wherein second
portion 910 is comprised of a material sufficiently malleable as to
distribute the force of first portion 908 upon an affected body
channel. First rod 902 further comprises ferromagnetic bars 912 and
914 proximate to first end 904 and second end 906, respectively.
Second rod 916 comprises a third end 918 and a fourth end 920.
Second rod 916 further comprises third portion 922 and fourth
portion 924, wherein third portion 922 is comprised of a material
sufficiently rigid as to exert a force upon a body channel, and
wherein fourth portion 924 is comprised of a material sufficiently
malleable as to distribute the force of third 922 upon an affected
body channel. Second rod 916 further comprises ferromagnetic bars
926 and 928 proximate to third end 918 and fourth end 920,
respectively. First rod 902 and second rod 916 each further
comprise biologically compatible sleeve 930 and 932 respectively.
In at least one embodiment, sleeves 930 and 932 may have the same
characteristics as described herein for sleeve 824. Sleeve 930 is
removably connected to first end 904 of first rod 902 and may
removably engage third end 918 of second rod 916. Sleeve 932 is
removably connected to second end 906 of first rod 902 and may
removably engage fourth end 920 of second rod 916.
[0058] In at least the embodiments described herein, permanent
magnetic materials may be used. In at least some embodiments, the
permanent magnetic materials are selected to be thin, smooth
ferromagnetic bars. Saturation hysteresis loop is an important
feature for these permanent magnet materials. During the process of
magnetizing the sample, the magnet is subjected to a field that
produces a flux density close to saturation. When the magnetizing
field is reduced to zero, the induction drops back to the original
value. If the magnetizing field is reversed, the magnetic poles of
the thin, smooth ferromagnetic bars are reversed.
[0059] A frequently used criterion of quality of a permanent magnet
is the (BH).sub.max product. This is the maximum value that can be
obtained by multiplying the corresponding B and H values at the
point of operation on the demagnetization curve, wherein B is the
magnetic flux density and H is the magnetic field strength. Here, H
is directly created by the electric current, I, in the magnetic
circuits. The magnetomotive force, F, is decided by the magnetic
flux (BA) and the distance, D, between the attractive magnetic
poles.
[0060] With a wide variation of properties available in permanent
magnet materials, the following criteria may be considered in
selecting the optimum material for the current application: 1)
application-magnetic field requirement, 2) physical or
mechanical-space factor, 3) weight, 4) stability requirements, 5)
ductility requirements, 6) biocompatibility and 7) cost. Dependent
on the therapeutic situation, various embodiments are envisioned
which emphasize different criteria.
[0061] Ferromagnetic bars used in at least some of the embodiments
may comprise many different materials dependent on the usage and
properties desired. In at least one embodiment, the ferromagnetic
bar may consist essentially of polymer-bonded neodymium-iron-boron
(Nd--Fe--B) magnets formed by compression molding, in which magnet
powders are mixed with a polymer carrier matrix, such as epoxy,
which then solidifies to give shape to the magnetic material.
Ferromagnetic bars used herein may also be comprised of a Heusler
alloy. Heusler alloys which may be used in an exemplary embodiment,
of a ferromagnetic bar, include, but are not limited to,
Fe.sub.80B.sub.20, carbon coated metal particles, Cu.sub.2MnAl,
Cu.sub.2MnIn, Cu.sub.2MnSn, Ni.sub.2MnAl, Ni.sub.2MnIn,
Ni.sub.2MnSn, Ni.sub.2MnSb, Co.sub.2MnAl, Co.sub.2MnSi,
Co.sub.2MnGa, Co.sub.2MnGe, Pd.sub.2MnAl, Pd.sub.2MnIn,
Pd.sub.2MnSn, and Pd.sub.2MnSb.
Computation of Magnetic Force
[0062] In at least some embodiments, the horizontal force, which is
the force determining the circumferential size of the bar (and
therefore the size of the deformed body channel), may be computed
in a number of ways. Referring to FIG. 3, when only B.sub.x is
considered, the stress tensor vector can be changed as:
P = [ | B x | 2 2 .mu. 0 0 0 - | B x | 2 2 .mu. 0 0 0 - | B x | 2 2
.mu. ] ( n x 0 0 ) = | B x | 2 2 .mu. [ 1 ] ##EQU00001##
[0063] The fringe loss of magnetic flux density is assumed to be
0.5 Teslas. For example, an exemplary embodiment of a deformation
device may comprise a left magnetic bar comprised of polymer-bonded
Nd--Fe--B magnets and a right magnetic bar comprised of Heusler
alloy or carbon-coated metal particles. When
|B.sub.x|=0.1.times.0.5=0.05 T, the pressure on the left and right
magnetic bars can be calculated as follows:
P = | B x | 2 2 .mu. = 0.05 2 8 .pi. .times. 10 - 7 = 1.0 ( KPa ) [
2 ] ##EQU00002##
[0064] When
area=.pi..times.(10.times.10.sup.-3).sup.2=3.14.times.10.sup.-4
m.sup.2, the maximum attractive magnetic force on the left and
right magnetic bars may be calculated as follows:
F=P.times.area=1.0.times.10.sup.3.times.3.14.times.10.sup.-4=0.314
(Newton) [3]
[0065] It should be noted that the aforementioned equations are
presented as merely one example of how such calculations may be
carried out. As such, these equations are by no means meant to be
limiting and additional embodiments may be carried out by other
calculations as well as would be apparent to one having ordinary
skill in the art after consideration of the present disclosure.
[0066] Referring to FIG. 10, at least one embodiment of power
source 1000 is described. In at least this embodiment, power source
1000 serves to supply an electrical current to the first wire in
electrical communication with a ferromagnetic bar, as described
herein, collectively referred to as magnetic material 1002. Passage
of electrical current through magnetic material 1002 may in at
least some embodiments form an inducer. The magnitude of the
magnetic force generated by the inducer depends on the material of
the magnet, such as the ferromagnetic bar, and on the amount of
current passed through the inducer. Increase of the level of
current supplied by energy supply 1004 raises the level of magnetic
force generated accordingly. Similarly, a decrease in the electric
current results in a decrease in the magnetic force. Even after the
electric current is turned off though, residual magnetic forces may
still remain.
[0067] Power source 1000, in at least one embodiment, comprises
magnetic material 1002, energy supply 1004, processor 1006, sensor
1008, and control mechanism 1010. Magnetic material 1002 is as
described in at least any one of the embodiments described herein.
For example, as described with respect to FIGS. 6-9, any one of the
ferromagnetic bars proximate to the ends of the first or second
bars may be in contact with a first wire. The first wire is
additionally in communication with energy supply 1004. Energy
supply 1004 may be internal or external to the body, and in at
least some embodiments energy supply 1004 may comprise a battery.
In at least some embodiments, energy supply 1004 may be implanted
subcutaneously in the body. Additionally, in at least one
embodiment, energy supply 1004 is operably connected to processor
1006.
[0068] Further, processor 1006 is operably connected to both sensor
1008 and control mechanism 1010. In at least this embodiment,
processor 1006 is operable to manage the information generated by
sensor 1008, and acts to implement the commands of control
mechanism 1010.
[0069] Sensor 1008, in at least one embodiment, serves to determine
the functionality of the deformation device, and/or the
characteristics of the body to which the deformation device
interacts. The monitoring carried out by sensor 1008 is operable to
detect a predetermined variable. In at least one embodiment, sensor
1008 may detect the deformation of the body channel. The
predetermined variables detectable by sensor 1008 may include any
of the flow rate of a material within the body channel, the level
of pressure exerted by the first rod or second rod on the body
channel, temperature, and the functional nature of the deformation
device. Readings from sensor 1008 may be supplied directly to
processor 1006. Further, the predetermined variables detected by
sensor 1008 may be altered either through processor 1006 or by
additional intervention, such as for example, mechanical
intervention.
[0070] Control mechanism 1010 serves in at least one embodiment as
the actuator for the deformation device. In at least some
embodiments, control mechanism 1010 signals processor 1006 to
activate energy supply 1004 so as to provide an electrical current
to magnetic material 1002. Further, control mechanism 1010 may also
serve to halt this supply of electrical current. The level of
electrical current supplied by energy supply 1004 may be of a
preset level. In at least one embodiment, control mechanism 1010
allows a range of electrical current to be supplied to magnetic
material 1002.
[0071] Manipulation of control mechanism 1010 may be accomplished
either automatically or manually. In the automatic manipulation of
control mechanism 1010, processor 1006 may monitor a variable, such
as time, which when reaching a preset amount may signal
communication mechanism 1010 to change the level of electrical
current supplied from energy supply 1004 to magnetic material 1002.
Further, in at least one embodiment, processor 1006 monitors the
data accumulated by sensor 1008 so as to modify the activity of
control mechanism 1010 should a preset variable be reached. For
example, should sensor 1008 sense that first rod 802 is exceeding a
preset threshold level of pressure exertion, processor 1006 would
signal control mechanism 1010 to decrease the level of electrical
current supplied by energy supply 1004 to magnetic material
1002.
[0072] Manual manipulation of control mechanism 1010 may be
accomplished instead of, or in addition to, automatic manipulation.
In at least some embodiments, manual manipulation may be
accomplished through physical interaction with control mechanism
1010 or by electrical communication with control mechanism 1010.
For example, the activation level of control mechanism 1010 may be
altered through the use of a remote control-type device.
[0073] In at least one embodiment, processor 1006 may record,
display and/or transmit data generated by deformation device 800.
Data generated by the deformation device may include measurements
taken by sensor 1008, instructions by control mechanism 1010,
levels of current supplied to magnetic material 1002. Processor
1006 may store this data in a capacity to be retrieved or displayed
at a later time. Display of the data by the processor may be in
form comprehendible to an individual. Further, processor 1006 may
transmit the data generated to a secondary processor for additional
uses.
[0074] Body channels, such as those illustrated in FIGS. 5A-C, may
comprise many different structures within the body. In at least one
embodiment, the body channel comprises a vessel within a body which
may serve to supply, or allow the passage therethrough of, a liquid
or solid. For example, a body channel may include any sphincter,
such as the upper esophageal sphincter, the lower esophageal (or
Cardia) sphincter, the pyloric sphincter, the Illeocecal sphincter,
the sphincter of Oddi, the urethral sphincter, the internal anal
sphincter, and external anal sphincter. Additionally, the vessels
which connect to, or supply, these sphincters will be considered
body channels.
[0075] Methods of use of at least one embodiment of the deformation
device are described herein. In at least one embodiment, a
deformation device comprising a first rod, a first wire, and a
power source is introduced proximate to a body channel. In this
embodiment, the first rod has a first end and a second end, a first
ferromagnetic bar proximate to the first end and a second
ferromagnetic bar proximate to the second end. Additionally, a
portion of the first wire is in contact with the first rod and is
electrically coupled with the power source. Following the
introduction of the deformation device, the first rod, or
optionally a plurality of rods, is then positioned so as to
substantially encircle a body channel. After positioning, the first
rod is secured so as to be substantially immobile. Securing the
first rod may be accomplished through any known means to a person
skilled in the art. For example, the first rod may be secured
through suture, biocompatible adhesives, or bindings. Following
securing of the first rod, an electrical current to the desired
level is supplied to the first wire to form an inductor.
Additionally, application of the electrical current in some
embodiments may cause a constriction of a body channel by the
first, or plurality of, rods, Optionally, the implantation of the
deformation device may include the introduction of a sleeve
material so as to protect a portion of the first rod from contact
with an external structure. The body channels which may be deformed
through this method include, but are not limited to the upper
esophageal sphincter, lower esophageal (or cardia) sphincter,
pyloric sphincter, Illeocecal sphincter, sphincter of Oddi,
urethral sphincter, internal anal sphincter, and external anal
sphincter. Additionally, body channels connected to the
above-mentioned sphincters maybe acted on as well in some
embodiments.
[0076] The method of deformation of a body channel, according to
one exemplary embodiment, may act to constrict a body channel for
the treatment of an abnormal, or undesired, condition. According to
an exemplary embodiment of a method disclosed herein, for the
treatment of gastroesophageal reflux disease, the embodiment
includes the steps of introducing deformation device 800 proximal
to the lower esophageal sphincter. Deformation device 800, in this
embodiment, comprises first rod 802 having first end 804 and second
end 806. First rod 802 further comprises first portion 808 and
second portion 810, wherein first portion 808 is comprised of a
material sufficiently rigid as to exert a force upon the lower
esophageal sphincter, and wherein second portion 810 is comprised
of a material sufficiently malleable as to distribute the force of
first portion 808 upon the lower esophageal sphincter, so as not to
inflict damage on the sphincter or surrounding structures. First
rod 802 further comprises ferromagnetic bars 812 and 814 proximate
to first end 804 and second end 806, respectively. Additionally,
first rod 802 further comprises two additional ferromagnetic bars
816 and 818 located between ferromagnetic bars 812 and 814, and
joint member 822 located between ferromagnetic bars 816 and 818.
Ferromagnetic bars 812, 814, 816, and 818 are in contact with a
wire electrically coupled to power supply 820. Power supply 820
comprises energy source 1004, processor 1006, sensor 1008, and
control mechanism 1010. Following introduction of deformation
device 800, deformation device 800 is positioned as to
substantially encircle the lower esophageal sphincter. Deformation
device 800 may then be secured at a point proximal to the lower
esophageal sphincter through use of sutures. Electrical current
from energy source 1004 is then applied to wire 824, and adjusted
either manually or automatically, as appropriate, to deform the
lower esophageal sphincter. Joint member 822 allows for an
increased capacity for the flexure of first rod 802. Sensor 1008
detects the flow of materials within the lower esophageal
sphincter, and deformation of the lower esophageal sphincter to
preset limits. Detection of values outsides the preset limits by
sensor 1008 triggers control mechanism 1010 to cause processor 1006
to increase or decrease the current supplied by energy supply 1004
as appropriate.
[0077] Additional embodiments of the method may affect additional
body channels such as the urinary sphincter to control urinary
incontinence, and the interior or exterior anal sphincter for
control of fecal incontinence. Deformation of the urinary sphincter
or surrounding vessels by an embodiment of the deformation device
may provide control of urinary output, and thus relief from urinary
incontinence. Control of urinary output, may in an embodiment be
performed manually by altering the electrical current supplied to
the deformation device. In an embodiment, this alteration in
current would serve to compress or release the urinary sphincter as
needed. Additionally, deformation of the interior or exterior anal
sphincter may be used to control fecal incontinence as was
described above for the control of urinary incontinence.
[0078] For deformation of a body channel, an embodiment of a
deformation device may interact with channels operably connected to
the body channel in question to accomplish the same desired effect.
For example, deformation of the esophagus may effect any area of
the esophagus as well as the lower or upper esophageal sphincter.
Additionally, deformation of the neck of the bladder may affect any
area of the urinary passage which comprises the urethra as well as
the urinary sphincter. Further, deformation of the rectal passage
may affect any area of the rectum as well as the internal anal
sphincter and external anal sphincter.
[0079] While various embodiments of devices, systems, and methods
for deforming a body channel have been described in considerable
detail herein, the embodiments are merely offered by way of
non-limiting examples of the invention described herein. Many
variations and modifications of the embodiments described herein
will be apparent to one of ordinary skill in the art in light of
the this disclosure. It will therefore be understood by those
skilled in the art that various changes and modifications may be
made, and equivalents may be substituted for elements thereof,
without departing from the scope of the invention. Indeed, this
disclosure is not intended to be exhaustive or to limit the scope
of the invention. The scope of the invention is to be defined by
the appended claims, and by their equivalents.
[0080] Further, in describing representative embodiments, the
disclosure may have presented a method and/or process as a
particular sequence of steps. However, to the extent that the
method or process does not rely on the particular order of steps
set forth herein, the method or process should not be limited to
the particular sequence of steps described. As one of ordinary
skill in the art would appreciate, other sequences of steps may be
possible. Therefore, the particular order of the steps disclosed
herein should not be construed as limitations on the claims. In
addition, the claims directed to a method and/or process should not
be limited to the performance of their steps in the order written,
and one skilled in the art can readily appreciate that the
sequences may be varied and still remain within the spirit and
scope of the present invention.
[0081] It is therefore intended that the invention will include,
and this description and the appended claims will encompass, all
modifications and changes apparent to those of ordinary skill in
the art based on this disclosure.
* * * * *